DEFENCATH (heparin sodium)
Defencath is a combination of taurolidine (an antimicrobial) and heparin (an anticoagulant) indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in a limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). Its use is specifically restricted to this patient population, as safety and effectiveness have not been established in other clinical settings.
How DEFENCATH Works
Defencath exerts a dual mechanism of action through its components: 1. **Heparin:** An anticoagulant that interacts with the plasma protein Antithrombin III. This interaction induces a conformational change that significantly enhances Antithrombin III's ability to inhibit activated coagulation factors, primarily Factor Xa and thrombin (Factor IIa), thereby preventing the formation of stable fibrin clots within the catheter. 2. **Taurolidine:** A thiadiazinane derivative that functions as a broad-spectrum antimicrobial agent, though its precise biochemical mechanism of action is not fully detailed in the primary MOA section, it serves to inhibit microbial growth and biofilm formation.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-11-15
- Patent Cliff
- 2042
- Routes
- N/A
- Dosage Forms
- SOLUTION
DEFENCATH Approval History
What DEFENCATH Treats
2 indicationsDEFENCATH is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Catheter-Related Bloodstream Infection
- Kidney Failure
DEFENCATH Target & Pathway
ProTarget
A key enzyme in the blood clotting cascade that converts prothrombin to thrombin. Inhibiting Factor Xa prevents clot formation, reducing risk of stroke in atrial fibrillation and treating/preventing venous thromboembolism.
DEFENCATH Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to DEFENCATH
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
57 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06453876 STRATIFY-II | STRATIFY-II 4.1 (10MAR2026) | Ph 3 | not yet recruiting | Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II) |
| NCT05848713 ATTACC-CAP | ATTACC-CAP OZM-129 | Ph 3 | recruiting | AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia |
| NCT04374799 | 2102 | Ph 3 | recruiting | Heparin vs Placebo for Cardiac Catheterization |
| NCT02591199 results posted | URG101-105 | Ph 2 | terminated | Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome |
| NCT06080074 TROLLEY | 72467 | Ph 2 | recruiting | Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System |
| NCT06381661 PALETTE | APHP240385 | Ph 2 | not yet recruiting | Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial |
| NCT05737121 | VNX001-111; Engage 2024 | Ph 2 | recruiting | Safety and Efficacy Study of VNX001 Compared to Its Individual Components (Lidocaine and Heparin) or Placebo in Subjects With IC/BPS |
| NCT06822426 | NUTRI-GUARD | Ph 3 | recruiting | Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC) |
| NCT04536272 RATE | 201900659 848018014, 7969 | Ph 3 | completed | Reduced Anticoagulation Targets in ECLS (RATE) |
| NCT02651428 results posted | LOCK-IT-100 | Ph 3 | completed | Study Assessing Safety & Effectiveness of a Catheter Lock Solution in Dialysis Patients to Prevent Bloodstream Infection |
| NCT05886998 | FMASU MD 238/2020 | Ph 3 | completed | Nebulized Heparin for Prevention of Acute Lung Injury in Smoke Inhalation Injury |
| NCT06646328 | FER-CIT-2016-01 2016-004361-12 | Ph 4 | terminated | Oxidative Stress and Circulating Nuclear DNA (cfDNA) in Acute Kidney Injury and Continuous Renal Replacement Therapies. |
| NCT04743011 EnHanCed results posted | UPECLIN-MB-2 | Ph 1, Ph 2 | completed | Enriched Heparin Anti COVID-19 Trial |
| NCT03867851 | NNCIT-02 | Ph 2 | terminated | Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation |
| NCT06365398 SELECT | SELECT XWHL-2018010 | Ph 4 | completed | Safety and Efficacy of Low-dose hEparinization in Cerebral Angiography sTudy |
| NCT04397510 | FHHep518 | Ph 4 | terminated | Nebulized Heparin for the Treatment of COVID-19 Induced Lung Injury |
| NCT04655586 ASPEN results posted | NAPc-201/301 | Ph 2, Ph 3 | completed | Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 |
| NCT00701623 Heparin | HEPCRI0208 | Ph 2, Ph 3 | withdrawn | Sodic Heparin Effectiveness of the Treatment of Burns |
| NCT03894904 results posted | HSC-MS-19-0059 | Ph 4 | completed | Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients |
| NCT02664155 VERDICT | 1508189 2016-000858-35 | Ph 3 | terminated | Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants |
| NCT04842292 results posted | 65139 | Ph 2 | terminated | Nebulized Heparin for COVID19-associated Acute Respiratory Failure |
| NCT02910518 | BEQ13941 2016-001498-34, U1111-1183-8636 | Ph 1 | completed | A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus |
| NCT03752437 | MDKR | Ph 4 | completed | Comparison of Two Dosages of Heparin Before Extracorporeal Circulation |
| NCT01823393 HEPAVALV | 9026 | Ph 4 | terminated | Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure |
| NCT00789308 | DAIT CIT-01 CIT-01, 2008-001210-25 | Ph 2 | completed | Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation |
| NCT04723563 INHALE-HEP | FHHep2121 | Ph 4 | completed | Nebulized Heparin for the Treatment of COVID-19 |
| NCT04485429 | 31180820600005249 | Ph 3 | withdrawn | Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia |
| NCT04372589 ATTACC | ATTACC OZM-113 | Ph 2, Ph 3 | completed | Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC) |
| NCT03672006 TOPCAT results posted | MCWisconsin | Ph 2 | completed | t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection |
| NCT03707418 | IRB00176475 | Ph 1 | withdrawn | Bivalirudin vs Heparin in ECMO Patients |
| NCT04042324 results posted | RMFPC-24 | Ph 1, Ph 2 | completed | A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients |
| NCT02206087 | PER977-01-002 | Ph 1, Ph 2 | completed | Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of PER977 Following Heparin |
| NCT02669589 RICH | UKM 14_0066 2014-004854-33, 03-AnIt-14 | Ph 4 | completed | Investigating Different Anticoagulants for Renal Replacement Therapy |
| NCT03081169 | 209199 | Ph 4 | withdrawn | Timing of VTE Prophylaxis in TBI |
| NCT02365285 RDVCGH results posted | 141552 | Ph 1, Ph 2 | completed | Racial Differences in Vagal Control of Glucose Homeostasis |
| NCT03422419 PROGRESS | IICT2017_PROGRESS | Ph 3 | withdrawn | TIPS or Anticoagulation in Portal Vein Thrombosis |
| NCT02565147 BIVAL results posted | MDCO-BIV-12-02 2012-002314-39 | Ph 3 | terminated | Bivalirudin Infusion for Ventricular Infarction Limitation |
| NCT02687256 | IRB 36142 | Ph 1 | completed | Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set |
| NCT02271126 | 932/2014 | Ph 1 | completed | TEG Anticoagulation Monitoring During ECMO |
| NCT02311231 VALIDATE | EudraCT nr: 2012-005260-10 | Ph 4 | completed | Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART |
| NCT01204333 TOACT | TOACT | Ph 2, Ph 3 | terminated | Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis |
| NCT01598883 | Altered Heparin Responsiveness | Ph 1 | completed | Understanding "Heparin Resistance" in Cardiac Surgery |
| NCT01976988 results posted | DVT | Ph 3 | completed | Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery |
| NCT02454491 VERMUT | 58 | Ph 4 | completed | Verapamil vs Heparin in Transradial Procedures |
| NCT01087723 EUROMAX results posted | TMC-BIV-08-03 | Ph 3 | completed | European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial |
| NCT02563041 CITRIM | UCPel | Ph 4 | completed | Comparative Effectiveness of 30%TSC and Heparin Lock Solution in Hemodialysis Catheters |
| NCT02493504 | SHBMU-001124 | Ph 4 | completed | Effects of Heparin on Arteriovenous Fistula Patency |
| NCT01464671 STATUS PCI | 119778 (IRB ID) | Ph 4 | terminated | Angiomax® or Unfractionated Heparin for Patients Undergoing Percutaneous Coronary Intervention |
| NCT01163097 results posted | 20070278 | Ph 1 | completed | Study to Characterize the Effect of Heparin on Palifermin Activity |
| NCT01696110 BRIGHT | SYNH20120001 2011BAI11B07 | Ph 4 | completed | BivaliRudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin :a Randomised Controlled Trial. |
Showing 50 of 57 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DEFENCATH FDA Label Details
Indications & Usage
FDA Label (PDF)DEFENCATH is indicated for the treatment of Catheter-Related Bloodstream Infection; Kidney Failure.
DEFENCATH Patents & Exclusivity
Patents (2 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DEFENCATH
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2042
- • 8 active patents
Trial Analysis
- • 57 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment